Tablets for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
| STAINES-UPON-THAMES, United Kingdom, Dec. 12, 2018 /PRNewswire/ -- SpecGx LLC, a subsidiary of Mallinckrodt plc (NYSE: MNK) that operates its Specialty Generics business, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) related to its New Drug Application (NDA) for its investigational abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride) tablets, USP for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
In the letter, the Agency provided guidance regarding areas of further evaluation necessary to resubmit the NDA for further review and potential approval of the drug, which was designed with properties to deter intravenous and intranasal abuse under the company’s 505(b)2 new drug application MNK-812. “We are evaluating the FDA’s letter and will request a meeting in the coming weeks to discuss it further,” said Matt Harbaugh, President, Specialty Generics. “We continue to believe this new abuse-deterrent formulation has the potential to mitigate opioid abuse and misuse, and though we’re disappointed by the FDA’s decision, we will continue to pursue a pathway to try to gain approval of the drug.” The company has for years been at the forefront of preventing prescription drug diversion and abuse, and has invested millions of dollars in a multi-pronged program to address opioid abuse. In addition to abuse-deterrent technology, those efforts include the purchase and donation of nearly two million drug disposal pouches, and working with policymakers, community leaders, law enforcement and industry partners to ensure the responsible use of pain medication and preventing unused medications from ending up in the wrong hands. These efforts will continue to be supported. Please click here for more information about these efforts. ABOUT MALLINCKRODT Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website. CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS CONTACTS Investor Relations Media Meredith Fischer
SOURCE Mallinckrodt plc |
Company Codes: NYSE:MNK |
View original content to download multimedia:
